BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBOT PMD

    MDR report key: 20678488 · Received November 13, 2024

    Report

    Report Number
    3014522447-2024-00001
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 18, 2024
    Report Date
    November 13, 2024
    Manufacturer
    MOBIUS MOBILITY LLC.
    Product Code
    IMK
    UDI-DI
    00857584008010
    PMA / PMN Number
    K210920
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MOBIUS MOBILITY RECEIVED A COPY OF A FACEBOOK POST FROM SOMEONE SAYING A CUSTOMER HAD BEEN INJURED. IT APPEARS FROM THE POST THAT THE WHEELS SLIPPED ON A RUG WHILE GOING BACK INTO THE HOUSE IN BALANCE MODE AND THE UNIT RAPIDLY AUTO TRANSITIONED TO 4-WHEEL MODE TO ENSURE STABILITY. PER THE FACEBOOK POST, THE AUTO-TRANSITION EVENT CAUSED THE CUSTOMER TO RECEIVE AN L1 COMPRESSION FRACTURE. PER THE IBOT USER MANUAL, THE IBOT SHOULD NOT BE USED ON ANY LOOSE FLOOR COVERINGS, INCLUDING LOOSE RUGS. WHEN USED ON A LOOSE SURFACE, BALANCE MODE CAN DETECT WHEN THE IBOT IS BEGINNING TO SLIP, AND THIS CAN CAUSE A RAPID AUTO TRANSITION TO MAINTAIN STABILITY AND PREVENT MORE SERIOUS ISSUES. MOBIUS MOBILITY WAS ABLE TO CONTACT THE USER AND OBTAIN VIDEO AND RETRIEVE THE LOGS FROM THE DEVICE ON (B)(6) 2024. EVENT/ALARM DATA CONFIRMS THE DEVICE ENTERED BALANCE MODE AT 14:42:10 ON 10/18/24. AT 14:48:48, THE DEVICE RECORDED A CONTROLLER ALERT (EVENT) INDICATING A BALANCE MODE LOSS OF TRACTION WITH AUTO-TRANSITION. NO OTHER RELEVANT EVENT/ALARM DATA IS PRESENT IN THE LOGS. THE DATA IS CONSISTENT WITH THE USER DESCRIPTION AND WITH THE PROVIDED VIDEO. THE DEVICE CLEARED A THRESHOLD IN BALANCE MODE ONTO A PIECE OF GREEN CARPET (TURF), WHICH WAS NOT SECURED TO THE FLOOR. THE TORQUE PROVIDED BY THE DEVICE WHEELS MOVED THE CARPET RESULTING IN THE DEVICE'S DETECTION OF LOSS OF TRACTION, AND AUTO-TRANSITION TO A STABLE 4-WHEEL MODE. THERE IS NO OTHER INFORMATION OR DATA CONTAINED IN THE LOGS OR INVESTIGATION RELEVANT TO THE REPORTED EVENT, AND NO INDICATION OF DEVICE MALFUNCTION. THE DEVICE BEHAVED AS EXPECTED.

    Description of Event or Problem · 0

    THE USER REPORTED BEING IN BALANCE MODE WHEN INCIDENT HAPPENED ON THEIR RAMP AS THEY DROVE OVER A LOOSE PIECE OF ARTIFICIAL TURF STYLE CARPET THAT HAD MOVED CLOSER TO THE BOTTOM OF THE RAMP OVER TIME. WHEN GOING UP THE RAMP THE CARPET SLIPPED CAUSING A LOSS OF TRACTION RESULTING IN A RAPID AUTO TRANSITION TO MAINTAIN STABILITY AND PREVENT MORE SERIOUS ISSUES. THIS RESULTED IN THE USER SUSTAINING A COMPRESSION FRACTURE OF THE L1 VERTEBRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938346 IBOT PMD IBOT IMK MOBIUS MOBILITY LLC. IBOT PMD N/A 00857584008010

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization